MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.The following information was requested but unavailable: does the surgeon believe that ethicon products (blake drain, vicryl & prolene sutures) involved caused and/or contributed to the post-, operative complications (abscess, surgical site infection, wound dehiscence) described in the article? -does the surgeon believe there was any deficiency with the ethicon products (blake drain, vicryl & prolene sutures) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications (abscess, surgical site infection, wound dehiscence).Were these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Events reported via mw # 2210968-2021-01143, 2210968-2021-01144.Citation: ann plast surg 2019;82: 667¿670.Doi: 10.1097/sap.0000000000001771.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article: "title: gluteal flaps revisited" authors: paige l.Myers, md, peter j.Krasniak, bs, serena j.Day, bs, and ronald p.Bossert, md citation: ann plast surg 2019;82: 667¿670.Doi: 10.1097/sap.0000000000001771.The authors described a modification of the previous technique of advancing bilateral fasciocutaneous gluteal flaps into the pelvic cavity for reconstruction.This operation is performed expeditiously in the prone position.The patient is spared a large anterior deficit but reaps the benefits of a robust reconstruction with minimal morbidity.This retrospective chart review involves 31 patients (average age: 59 years, ranging from 29 to 85 years; average bmi: 28 kg/m2) who were identified as undergoing reconstruction with either unilateral or bilateral gluteal fasciocutaneous v-y advancement flaps for complex perineal defect closure from july 1, 2012, to february 28, 2018.During the procedure, the trailing edge of the de-epithelialized segment is sutured to the contralateral levator complex, thus securing the majority of the flap directly into the pelvis over a 19f round blake drain.A flap is raised in similar fashion from the contralateral side and advanced medially to the remaining flap segment.Closure is performed in layers with 2¿0 vicryl suture placed in the superficial fascial system, and interrupted 2-0 prolene sutures at 2-cm intervals are performed over closed suction drains in the subcutaneous space (with 1 drain already having been placed directly into the pelvis).Initially, absorbable mesh was placed in the defect for further support at the level of the pelvic brim.With the evolution of the practice, the mesh was deemed unnecessary with positive results.Of the 31 patients, 12 did undergo mesh placement (mesh group), whereas 19 did not (no-mesh group).Reported complications for the mesh group included total complications (n-11) including major complications (n-2) consisting of abscess (n-2) requiring return to the operating room of abscess drainage, and minor complications (n-8) consisting of surgical site infection (ssi) (n-3) and dehiscence (n-6) which healed with conservative management.Reported complications for the no mesh group included total complications (n-7) including minor complications (n-7) consisting of surgical site infection (ssi) (n-1), and dehiscence (n-6) which healed with conservative management.The authors demonstrated an approach for perineal reconstruction, which is safe and effective and does not create functional donor site impairment while imparting an acceptable complication profile.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 11300204
• MDR Text Key: 230930754
• Report Number: 2210968-2021-01142
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention